Solvonis Therapeutics（SLVN.F）株式概要ソルボニス・セラピューティクス社は、臨床段階のバイオ医薬品会社で、依存症や精神疾患の新薬を開発している。 詳細SLVN.F ファンダメンタル分析スノーフレーク・スコア評価1/6将来の成長0/6過去の実績0/6財務の健全性4/6配当金0/6リスク分析収益が 100 万ドル未満 ( £0 )キャッシュランウェイが1年未満である 株式の流動性は非常に低い 現在は利益が出ておらず、今後3年間で利益が出る見込みはない +1 さらなるリスクすべてのリスクチェックを見るSLVN.F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW493,086 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG493,086 investors already sharing narrativesYour Fair ValueUS$Current PriceUS$0.0005該当なし内在価値ディスカウントEst. Revenue$PastFuture-6m587k2016201920222025202620282031Revenue UK£0.07Earnings UK£0.01AdvancedSet Fair ValueView all narrativesSolvonis Therapeutics plc 競合他社Oncotelic TherapeuticsSymbol: OTCPK:OTLCMarket cap: US$17.2mWerewolf TherapeuticsSymbol: NasdaqGS:HOWLMarket cap: US$19.6mSynlogicSymbol: OTCPK:SYBXMarket cap: US$8.3mLite StrategySymbol: NasdaqCM:LITSMarket cap: US$34.4m価格と性能株価の高値、安値、推移の概要Solvonis Therapeutics過去の株価現在の株価UK£0.000552週高値UK£0.00752週安値UK£0.0001ベータ1.211ヶ月の変化-75.00%3ヶ月変化-75.00%1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化-50.00%最新ニュースお知らせ • Jun 22Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD.お知らせ • May 28Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdomお知らせ • Mar 12Solvonis Therapeutics plc Announces Selection of SVN-114 as Lead Candidate from its Proprietary SVN-SDN-14 Discovery ProgrammeSolvonis Therapeutics plc announced the selection of SVN-114 as the lead candidate from the Company's proprietary SVN-SDN-14 discovery programme targeting Post-Traumatic Stress Disorder ("PTSD"), a condition affecting more than 20 million people worldwide for which effective pharmacological treatment options remain limited. The selection follows compelling pharmacology results from preclinical studies conducted by Evotec SE, in which SVN-114 demonstrated balanced modulation of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET"), key brain chemicals involved in mood, emotion and social behaviour. Following review of the pharmacology data, the Company's Scientific Advisory Committee, led by Professor David Nutt, agreed to designate SVN-114 as the programme's lead candidate, marking an important milestone for Solvonis' proprietary CNS discovery platform. Mechanism designed to support therapeutic engagement: The SVN-SDN-14 series is a class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with PTSD. By modulating neurochemical pathways associated with trust, empathy and social bonding, compounds in this series, including SVN-114, are intended to help patients rebuild interpersonal relationships and engage more effectively in therapy. Novel chemistry supported by international patent applications: SVN-114 originates from a proprietary chemical series discovered through Solvonis' internal research programme. Composition-of-matter patent applications have been filed internationally covering both the compound class and its pharmaceutical applications.お知らせ • Jan 07+ 1 more updateSolvonis Therapeutics PLC Appoints Paul Rutherford Carter as Director, Effective October 27, 2025Solvonis Therapeutics PLC has appointed Paul Rutherford Carter as a director. The appointment was effective on October 27, 2025.お知らせ • Oct 28Solvonis Therapeutics plc Appoints Paul Carter as Non-Executive Director, Effective 27 October 2025Solvonis Therapeutics plc announced the appointment of Paul Carter as Non-Executive Director, effective 27 October 2025. Paul Carter is a highly accomplished global biopharmaceutical leader with nearly three decades of senior executive experience spanning commercial, operational, and strategic leadership roles. He has built and scaled businesses across Europe, North America, and Asia, combining deep operational expertise with a proven record of driving transformational growth and delivering long-term shareholder value. Paul currently serves as Non-Executive Chair of Clinigen Group plc. He is also Chair of Memo Therapeutics AG and Chair of Kyowa Kirin International plc. In addition, Paul serves as Non-Executive Director at Immatics N.V. He previously held senior global roles including Executive Vice President and Chief Commercial Officer at Gilead Sciences Inc., where he oversaw international operations across 38 markets and delivered annual revenues exceeding USD 30 billion. His appointment strengthens the Solvonis Board as the Company continues to advance its differentiated CNS pipeline and execute its capital-efficient, licensing-first growth strategy across addiction, psychiatry, and neurology.お知らせ • Oct 17Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million.Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 378,787,876 Price\Range: £0.0033 Transaction Features: Subsequent Direct Listing最新情報をもっと見るRecent updatesお知らせ • Jun 22Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD.お知らせ • May 28Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdomお知らせ • Mar 12Solvonis Therapeutics plc Announces Selection of SVN-114 as Lead Candidate from its Proprietary SVN-SDN-14 Discovery ProgrammeSolvonis Therapeutics plc announced the selection of SVN-114 as the lead candidate from the Company's proprietary SVN-SDN-14 discovery programme targeting Post-Traumatic Stress Disorder ("PTSD"), a condition affecting more than 20 million people worldwide for which effective pharmacological treatment options remain limited. The selection follows compelling pharmacology results from preclinical studies conducted by Evotec SE, in which SVN-114 demonstrated balanced modulation of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET"), key brain chemicals involved in mood, emotion and social behaviour. Following review of the pharmacology data, the Company's Scientific Advisory Committee, led by Professor David Nutt, agreed to designate SVN-114 as the programme's lead candidate, marking an important milestone for Solvonis' proprietary CNS discovery platform. Mechanism designed to support therapeutic engagement: The SVN-SDN-14 series is a class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with PTSD. By modulating neurochemical pathways associated with trust, empathy and social bonding, compounds in this series, including SVN-114, are intended to help patients rebuild interpersonal relationships and engage more effectively in therapy. Novel chemistry supported by international patent applications: SVN-114 originates from a proprietary chemical series discovered through Solvonis' internal research programme. Composition-of-matter patent applications have been filed internationally covering both the compound class and its pharmaceutical applications.お知らせ • Jan 07+ 1 more updateSolvonis Therapeutics PLC Appoints Paul Rutherford Carter as Director, Effective October 27, 2025Solvonis Therapeutics PLC has appointed Paul Rutherford Carter as a director. The appointment was effective on October 27, 2025.お知らせ • Oct 28Solvonis Therapeutics plc Appoints Paul Carter as Non-Executive Director, Effective 27 October 2025Solvonis Therapeutics plc announced the appointment of Paul Carter as Non-Executive Director, effective 27 October 2025. Paul Carter is a highly accomplished global biopharmaceutical leader with nearly three decades of senior executive experience spanning commercial, operational, and strategic leadership roles. He has built and scaled businesses across Europe, North America, and Asia, combining deep operational expertise with a proven record of driving transformational growth and delivering long-term shareholder value. Paul currently serves as Non-Executive Chair of Clinigen Group plc. He is also Chair of Memo Therapeutics AG and Chair of Kyowa Kirin International plc. In addition, Paul serves as Non-Executive Director at Immatics N.V. He previously held senior global roles including Executive Vice President and Chief Commercial Officer at Gilead Sciences Inc., where he oversaw international operations across 38 markets and delivered annual revenues exceeding USD 30 billion. His appointment strengthens the Solvonis Board as the Company continues to advance its differentiated CNS pipeline and execute its capital-efficient, licensing-first growth strategy across addiction, psychiatry, and neurology.お知らせ • Oct 17Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million.Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 378,787,876 Price\Range: £0.0033 Transaction Features: Subsequent Direct Listing株主還元SLVN.FUS BiotechsUS 市場7D-86.8%-2.0%0.1%1Yn/a34.9%20.3%株主還元を見る業界別リターン: SLVN.FがUS Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: SLVN.F US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is SLVN.F's price volatile compared to industry and market?SLVN.F volatilitySLVN.F Average Weekly Movementn/aBiotechs Industry Average Movement10.3%Market Average Movement7.3%10% most volatile stocks in US Market16.7%10% least volatile stocks in US Market3.2%安定した株価: SLVN.Fの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のSLVN.Fのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト20176Anthony Tennysonsolvonis.comソルボニス・セラピューティクス社は、臨床段階にあるバイオ医薬品会社で、依存症や精神疾患のための新薬を開発している。同社はNMDA受容体拮抗薬SVN-001を開発しており、重度アルコール使用障害の治療薬として臨床第III相試験を実施中であるほか、中等度から重度のアルコール使用障害の治療薬として臨床第I相試験を完了したSVN-002も開発している。前臨床段階の製品候補としては、心的外傷後ストレス障害治療薬のSVN-SDN-14がある。同社は以前Graft Polymer (UK) Plcとして知られていたが、2025年1月にSolvonis Therapeutics plcに社名を変更した。Solvonis Therapeutics plcは2017年に法人化され、英国ロンドンに本社を置いている。もっと見るSolvonis Therapeutics plc 基礎のまとめSolvonis Therapeutics の収益と売上を時価総額と比較するとどうか。SLVN.F 基礎統計学時価総額US$14.77m収益（TTM）-US$7.69m売上高(TTM)n/a0.0xP/Sレシオ-1.9xPER（株価収益率SLVN.F は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計SLVN.F 損益計算書（TTM）収益UK£0売上原価UK£0売上総利益UK£0その他の費用UK£5.74m収益-UK£5.74m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.00084グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率1.2%SLVN.F の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/13 04:34終値2026/07/10 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Solvonis Therapeutics plc 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Robert SassoonWater Tower Research LLC
お知らせ • Jun 22Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD.
お知らせ • May 28Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdom
お知らせ • Mar 12Solvonis Therapeutics plc Announces Selection of SVN-114 as Lead Candidate from its Proprietary SVN-SDN-14 Discovery ProgrammeSolvonis Therapeutics plc announced the selection of SVN-114 as the lead candidate from the Company's proprietary SVN-SDN-14 discovery programme targeting Post-Traumatic Stress Disorder ("PTSD"), a condition affecting more than 20 million people worldwide for which effective pharmacological treatment options remain limited. The selection follows compelling pharmacology results from preclinical studies conducted by Evotec SE, in which SVN-114 demonstrated balanced modulation of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET"), key brain chemicals involved in mood, emotion and social behaviour. Following review of the pharmacology data, the Company's Scientific Advisory Committee, led by Professor David Nutt, agreed to designate SVN-114 as the programme's lead candidate, marking an important milestone for Solvonis' proprietary CNS discovery platform. Mechanism designed to support therapeutic engagement: The SVN-SDN-14 series is a class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with PTSD. By modulating neurochemical pathways associated with trust, empathy and social bonding, compounds in this series, including SVN-114, are intended to help patients rebuild interpersonal relationships and engage more effectively in therapy. Novel chemistry supported by international patent applications: SVN-114 originates from a proprietary chemical series discovered through Solvonis' internal research programme. Composition-of-matter patent applications have been filed internationally covering both the compound class and its pharmaceutical applications.
お知らせ • Jan 07+ 1 more updateSolvonis Therapeutics PLC Appoints Paul Rutherford Carter as Director, Effective October 27, 2025Solvonis Therapeutics PLC has appointed Paul Rutherford Carter as a director. The appointment was effective on October 27, 2025.
お知らせ • Oct 28Solvonis Therapeutics plc Appoints Paul Carter as Non-Executive Director, Effective 27 October 2025Solvonis Therapeutics plc announced the appointment of Paul Carter as Non-Executive Director, effective 27 October 2025. Paul Carter is a highly accomplished global biopharmaceutical leader with nearly three decades of senior executive experience spanning commercial, operational, and strategic leadership roles. He has built and scaled businesses across Europe, North America, and Asia, combining deep operational expertise with a proven record of driving transformational growth and delivering long-term shareholder value. Paul currently serves as Non-Executive Chair of Clinigen Group plc. He is also Chair of Memo Therapeutics AG and Chair of Kyowa Kirin International plc. In addition, Paul serves as Non-Executive Director at Immatics N.V. He previously held senior global roles including Executive Vice President and Chief Commercial Officer at Gilead Sciences Inc., where he oversaw international operations across 38 markets and delivered annual revenues exceeding USD 30 billion. His appointment strengthens the Solvonis Board as the Company continues to advance its differentiated CNS pipeline and execute its capital-efficient, licensing-first growth strategy across addiction, psychiatry, and neurology.
お知らせ • Oct 17Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million.Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 378,787,876 Price\Range: £0.0033 Transaction Features: Subsequent Direct Listing
お知らせ • Jun 22Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD.
お知らせ • May 28Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdom
お知らせ • Mar 12Solvonis Therapeutics plc Announces Selection of SVN-114 as Lead Candidate from its Proprietary SVN-SDN-14 Discovery ProgrammeSolvonis Therapeutics plc announced the selection of SVN-114 as the lead candidate from the Company's proprietary SVN-SDN-14 discovery programme targeting Post-Traumatic Stress Disorder ("PTSD"), a condition affecting more than 20 million people worldwide for which effective pharmacological treatment options remain limited. The selection follows compelling pharmacology results from preclinical studies conducted by Evotec SE, in which SVN-114 demonstrated balanced modulation of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET"), key brain chemicals involved in mood, emotion and social behaviour. Following review of the pharmacology data, the Company's Scientific Advisory Committee, led by Professor David Nutt, agreed to designate SVN-114 as the programme's lead candidate, marking an important milestone for Solvonis' proprietary CNS discovery platform. Mechanism designed to support therapeutic engagement: The SVN-SDN-14 series is a class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with PTSD. By modulating neurochemical pathways associated with trust, empathy and social bonding, compounds in this series, including SVN-114, are intended to help patients rebuild interpersonal relationships and engage more effectively in therapy. Novel chemistry supported by international patent applications: SVN-114 originates from a proprietary chemical series discovered through Solvonis' internal research programme. Composition-of-matter patent applications have been filed internationally covering both the compound class and its pharmaceutical applications.
お知らせ • Jan 07+ 1 more updateSolvonis Therapeutics PLC Appoints Paul Rutherford Carter as Director, Effective October 27, 2025Solvonis Therapeutics PLC has appointed Paul Rutherford Carter as a director. The appointment was effective on October 27, 2025.
お知らせ • Oct 28Solvonis Therapeutics plc Appoints Paul Carter as Non-Executive Director, Effective 27 October 2025Solvonis Therapeutics plc announced the appointment of Paul Carter as Non-Executive Director, effective 27 October 2025. Paul Carter is a highly accomplished global biopharmaceutical leader with nearly three decades of senior executive experience spanning commercial, operational, and strategic leadership roles. He has built and scaled businesses across Europe, North America, and Asia, combining deep operational expertise with a proven record of driving transformational growth and delivering long-term shareholder value. Paul currently serves as Non-Executive Chair of Clinigen Group plc. He is also Chair of Memo Therapeutics AG and Chair of Kyowa Kirin International plc. In addition, Paul serves as Non-Executive Director at Immatics N.V. He previously held senior global roles including Executive Vice President and Chief Commercial Officer at Gilead Sciences Inc., where he oversaw international operations across 38 markets and delivered annual revenues exceeding USD 30 billion. His appointment strengthens the Solvonis Board as the Company continues to advance its differentiated CNS pipeline and execute its capital-efficient, licensing-first growth strategy across addiction, psychiatry, and neurology.
お知らせ • Oct 17Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million.Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 378,787,876 Price\Range: £0.0033 Transaction Features: Subsequent Direct Listing
